Clinical Trial: Phase 2/3 Oxabact Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2/3, Double-blind, Randomized, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of OxabactTM to Reduce Urinary Oxalate in Subjects With Primary

Brief Summary: The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering urinary oxalate levels in patients with primary hyperoxaluria.

Detailed Summary:
Sponsor: OxThera

Current Primary Outcome: Percentage change in urinary oxalate levels (expressed as molar oxalate to creatinine ratio) from Baseline to Week 24 [ Time Frame: 24 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percentage change in urinary oxalate levels (expressed as molar oxalate to creatinine ratio) from Baseline to Week 8 [ Time Frame: 8 weeks ]
  • Percentage change in urinary oxalate levels (expressed as molar oxalate to creatinine ratio) from Baseline to Week 24 in subsets of subjects defined by baseline urinary oxalate level, above and below median at screening [ Time Frame: 24 weeks ]
  • Percentage change in urinary oxalate levels (expressed as molar oxalate to creatinine ratio) from Baseline to Week 24 in subsets of subjects defined by concomitant vitamin B6 therapy and no vitamin B6 therapy, in PH type I [ Time Frame: 24 weeks ]
  • Percentage change in urinary oxalate levels (expressed as molar oxalate to creatinine ratio) from Baseline to Week 24 in subsets of subjects defined by eGFR of ≥90 mL/min/1.73m2 and < 90 mL/min/1.73m2 [ Time Frame: 24 weeks ]
  • Percentage change in urinary oxalate levels (expressed as molar oxalate to creatinine ratio) from Baseline to Week 24 in subsets of subjects defined by PH Type I and PH Type II [ Time Frame: 24 weeks ]
  • Percentage change in urinary oxalate levels (expressed as molar oxalate to creatinine ratio) from Baseline to Week 24 in subsets of subjects defined by age below 18 and age 18 or above [ Time Frame: 24 weeks ]
  • Percentage of subjects who have ≥20% reduction from Baseline urinary oxalate at Week 24 [ Time Frame: 24 weeks ]
  • Percentage change in plasma oxalate levels [ Time Frame: 24 weeks ]
  • Frequency of Stone Events (i.e. nephrolithiasis or markers thereof) [ Time Frame: 24 weeks ]
  • Correlation between percentage change in plasma oxalate levels and percentage change in urinary oxalate levels, from Baseline to Week 24 [ Time Frame: 24 weeks ]
  • Adverse events (AEs), hematology, clinical chemistry, urinalysis. [ Time Frame: 24 weeks ]


Original Secondary Outcome: Same as current

Information By: OxThera

Dates:
Date Received: December 18, 2009
Date Started: December 2009
Date Completion:
Last Updated: May 7, 2013
Last Verified: May 2012